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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00468585 |
The purpose of this study is to find out what effects (both good and bad) that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy, bevacizumab. Capecitabine (Xeloda®) is an anticancer drug that was approved by FDA in 1998 for treating metastatic breast cancer. Capecitabine is a pill that blocks the way cancer cells multiply and grow. Usually, this medicine is taken twice a day for fourteen days in a row.
Patients then get a break from the drug for seven days. With this schedule and usual dose, some patients on capecitabine have experienced side effects that interfered with their daily comfort.Different doses and schedules of capecitabine have been studied in animal studies and in people with colon cancer. Mathematic modeling has been used to better understand these results.Information from these experiments leads us to ask if 7 days of treatment with capecitabine followed by a 7-day break is both safer and more active against breast cancer. The study you are considering is a first step in this direction and is designed to demonstrate both safety and activity.
Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need to grow. Women whose breast cancer spread to other parts of their bodies lived longer without their cancers growing when they were treated with bevacizumab and chemotherapy. Bevacizumab was tested with the 14-day/7-day schedule of capecitabine. These two medicines are safe when given together and seem to work better against breast cancer than capecitabine alone.
This study is designed to answer the questions:
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Capecitabine and Bevacizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Multicenter, Phase I/II Study of Every Other Week Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model |
Estimated Enrollment: | 40 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
In the Phase I portion of the study, a standard three patient per cohort dose escalation scheme will be used, treating between 6 and 36 patients with biweekly capecitabine monotherapy. There will be no intrapatient dose escalation. The starting dose of capecitabine is 1,500 mg twice daily. Capecitabine will be administered orally in two divided doses daily on Days 1 through 7 and Days 15 through 21 in a 28 day cycle.
The Phase II trial has a Simon mini-max two-stage design. The treatment dose of capecitabine as determined in the Phase I portion of this trial will be administered orally in two divided doses daily on Days 1 through 7 and Days 15 through 21 in a 28 day cycle. Phase II patients will receive bevacizumab 10 mg/kg intravenously every 2 weeks concurrently with oral capecitabine. Patients will be evaluated for toxicity between Days 3 to 5.
A. Primary Objectives:
• To estimate the efficacy of every other week capecitabine and bevacizumab in patients with metastatic breast cancer in terms of overall response rate (complete response (CR) + partial response (PR)) when administered at the MTD of capecitabine determined by the phase I portion of this trial.
B. Secondary Objectives:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Non-malignant systemic disease (cardiovascular, renal, hepatic etc) that would preclude any of the study therapy drugs. Specifically excluded are the following cardiac conditions:
Contact: Tiffany Traina, MD | 646-888-4558 | trainat@mskcc.org |
Contact: Clifford Hudis, MD | 212-639-5449 | hudisc@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Tiffany Traina, MD 212-639-5209 trainat@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center 1275 York Avenue | Recruiting |
New York, New York, United States, 10021 | |
Contact: Tiffany Traina, MD 212-639-5209 trainat@mskcc.org | |
Principal Investigator: Tiffany Traina, MD | |
Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Tiffany Traina, MD 212-639-5209 trainta@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States, 11570 | |
Contact: Tiffany Traina, MD 212-639-5209 trainat@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Recruiting |
Sleepy Hollow, New York, United States, 10591 | |
Contact: Tiffany Traina, MD 212-639-5209 trainat@mskcc.org |
Principal Investigator: | Tiffany Traina, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan Kettering Cancer Center ( Tiffany A. Traina, MD ) |
Study ID Numbers: | 05-030 |
Study First Received: | May 2, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00468585 |
Health Authority: | United States: Institutional Review Board |
Breast cancer Metastatic breast cancer Breast Metastatic |
Capecitabine Skin Diseases Breast Neoplasms Bevacizumab Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |